May 28, 2003

FDA and Bureau of Customs and Border Protection Announce Steps to Streamline Collection of Information on Food Imports

This week FDA and the Bureau of Customs and Border Protection (CBP) jointly announced that as a result of continued collaborations between the two agencies, food importers will be able to provide prior notice to both agencies simultaneously using Customs' existing information technology system, the Automated Commercial System (ACS). ACS is the system importers and brokers currently use to file entries of imported products, including food. The Bioterrorism Act requires FDA to receive prior notice of food imported or offered for import into the U.S. beginning Dec.12, 2003. As stated in the press release, as a result of continued discussions between FDA and Customs, the two agencies have determined that ACS can be modified by the statutory deadline to provide for receipt of prior notice information from the submitter/filer and transmission to FDA via ACS. The complete press release can be seen at http://www.cfsan.fda.gov/~lrd/fpbtact4.html.

Because FDA is still in the process of developing the final rule, we are unable to discuss aspects of the final rule or our deliberations without written authorization from the FDA Commissioner, Dr. Mark McClellan. Dr. McClellan has given us a very limited authorization to issue this announcement, but we are not able to address any other aspects of the final rule at this time.

FDA and Customs will continue to work on the implementation issues and are committed to ensuring that ACS will be able to receive one submission that will satisfy both FDA's prior notice and Customs' entry requirements for imported food shipments by the statutory deadline.